NCT01232504

Brief Summary

We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 27, 2014

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

3.5 years

First QC Date

October 25, 2010

Results QC Date

January 26, 2014

Last Update Submit

October 27, 2014

Conditions

Mycoses

Keywords

Allo-HSCTrhGM-CSFSystemic fungal infection (SFI)

Outcome Measures

Primary Outcomes (1)

  • Incidences of Invasive Fungal Diseases (IFD)

    The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation

    100 day post transplant

Secondary Outcomes (8)

  • Hematological Engraftment

    100 days post transplant

  • Transplant Related Mortality

    100 days post transplant

  • Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)

    100 days post transplant

  • IFD Related Mortality

    3-1099 days

  • Relapse Related Mortality

    3～1099 days

  • +3 more secondary outcomes

Study Arms (3)

rhGM-CSF group

EXPERIMENTAL

subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily

Drug: rhGM-CSF group

rhG-CSF+rhGM-CSF group

ACTIVE COMPARATOR

a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each

Drug: rhG-CSF+rhGM-CSF group

rhG-CSF group

ACTIVE COMPARATOR

subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily

Drug: rhG-CSF group

Interventions

rhGM-CSF groupDRUG

subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).

Also known as: Topleucon®, Granulocyte Macrophage Colony Stimulating Factor
rhGM-CSF group
rhG-CSF+rhGM-CSF groupDRUG

a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).

Also known as: Topleucon®, Granulocyte Macrophage Colony Stimulating Factor, Granulocyte Colony Stimulating Factor
rhG-CSF+rhGM-CSF group
rhG-CSF groupDRUG

subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).

Also known as: Granulocyte Colony Stimulating Factor, Topleucon®
rhG-CSF group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 14\~60 years old
  • Allogenic hematological stem cell transplantation(HSCT) patients.
  • Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase \< 2 upper limit of normal, and/or total bilirubin \< 2.5 upper limit of normal, creatinine \< upper limit of normal.
  • Informed consent.

You may not qualify if:

  • Evidence of proven, probable or possible fungal infection at the time of enrollment.
  • Patients were receiving anti-fungal treatment with proven SFI before transplantation.
  • A history of hypersensitivity to G-CSF or GM-CSF.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Wuhan Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Related Publications (1)

  • Wan L, Zhang Y, Lai Y, Jiang M, Song Y, Zhou J, Zhang Z, Duan X, Fu Y, Liao L, Wang C. Effect of Granulocyte-Macrophage Colony-Stimulating Factor on Prevention and Treatment of Invasive Fungal Disease in Recipients of Allogeneic Stem-Cell Transplantation: A Prospective Multicenter Randomized Phase IV Trial. J Clin Oncol. 2015 Dec 1;33(34):3999-4006. doi: 10.1200/JCO.2014.60.5121. Epub 2015 Sep 21.

    PMID: 26392095DERIVED

MeSH Terms

Conditions

Mycoses

Interventions

Granulocyte-Macrophage Colony-Stimulating FactorGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Limitations and Caveats

The limitations of the current study included the lack of blinding and placebo group.

Results Point of Contact

Title
Chun Wang
Organization
Department of Hematology, Shanghai Jiao Tong University Affiliated First People's Hospital, China
wangchun2@medmail.com.cn

Study Officials

  • Chun Wang, M.D.

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

November 2, 2010

Study Start

September 1, 2009

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

November 4, 2014

Results First Posted

October 27, 2014

Record last verified: 2014-10

Locations

CN(5)